Primary DysmenorrheaNCT05178589
The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief
A study testing One Unit TENS and Two Unit TENS in people with Primary Dysmenorrhea, run by University of Southern California at 1 site in United States.
Trial summary
The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- One Unit TENS and Two Unit TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year
- BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths
- Not taking contraception or other types of medication that could influence reproductive status
- Regular menstruation
- Medically free from chronic diseases
- Free from known gynecological problems (ie. Endometriosis, Fibroids, Ovarian Cysts)
- History of analgesic pill intake during menstruation
- No pelvic pathology
Who cannot join
- Amenorrhea
- On a form of contraception
- Secondary dysmenorrhea and/or other gynecological problems that may cause pain
- No discomfort, pain, or other symptoms during menstruation
- History of surgery over lower abdomen area
- Allergy to ibuprofen
Show all 17Show fewer
- Cardiac disability
- Pacemaker
- Arterial disease
- Uncontrolled hemorrhage
- Blood clots
- Pregnancy or trying to become pregnant
- Cancerous lesions
- Exposed metal implants
- History of seizures
- Sensory or mental impairment
- Unstable fractures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California Health Sciences Campus Center for Health Professions
Los Angeles, California, 90033
About this study
Official title: The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief: A Randomized Control Trial
The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage.
- Conditions
- Primary Dysmenorrhea
- Being tested
- One Unit TENS, Two Unit TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Unit TENSDevice
Also called PowerDot
TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Single unit TENS was administered via 2 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day.
Two Unit TENSDevice
Also called PowerDot
TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Double unit TENS was administered via 4 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen. |
| One Unit TENS | Experimental | Participants will use one-unit TENS set-up where the TENS unit has 2 channels. Receives: Device: One Unit TENS |
| Two Unit TENS | Experimental | Participants will use a two-unit TENS set-up where the TENS unit has 4 channels. Receives: Device: Two Unit TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic effects of TENS on primary dysmenorrhea.
To determine whether TENS will reduce pain symptoms in those with primary dysmenorrhea. Subjective pain will be assessed using an 11 point visual analog scale (VAS). The scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
Measured: 1 month
Secondary outcomes (1)
Change in analgesic pill consumption during menstruation
Participants will be administered a daily survey where they will be asked to record analgesic pill intake throughout the day.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Mar 2022
- Primary completion27 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a randomized cross-over design over the course of 3 menstrual cycles. Each menstruation phase begins on the first day of menstruation until the last day of menstruation (disappearance of bleeding). Each participant will participate in 3 randomized conditions: control (no TENS), one-unit TENS, and two-unit TENS.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Schroeder, University of Southern California
- Investigators
- Todd Schroeder, PhD, Principal investigator, Associated Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178589
- Sponsor's protocol ID
- HS-21-00629
- Status last verified
- Oct 2023
- First submitted
- 1 Dec 2021
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
McLagan B, Dexheimer J, Strock N, Goldstein S, Guzman S, Erceg D, Schroeder ET. The role of transcutaneous electrical nerve stimulation for menstrual pain relief: A randomized control trial. Womens Health (Lond). 2024 Jan-Dec;20:17455057241266455. doi: 10.1177/17455057241266455.
PubMed 39066557
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05178589
- Acronym / sponsor ID
- HS-21-00629
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized cross-over design over the course of 3 menstrual cycles. Each menstruation phase begins on the first day of menstruation until the last day of menstruation (disappearance of bleeding). Each participant will participate in 3 randomized conditions: control (no TENS), one-unit TENS, and two-unit TENS.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen. |
| One Unit TENS | Experimental | Device: One Unit TENSParticipants will use one-unit TENS set-up where the TENS unit has 2 channels. |
| Two Unit TENS | Experimental | Device: Two Unit TENSParticipants will use a two-unit TENS set-up where the TENS unit has 4 channels. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- History of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year
- BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths
- Not taking contraception or other types of medication that could influence reproductive status
- Regular menstruation
- Medically free from chronic diseases
Key exclusion criteria (17 listed)
- Amenorrhea
- On a form of contraception
- Secondary dysmenorrhea and/or other gynecological problems that may cause pain
- No discomfort, pain, or other symptoms during menstruation
- History of surgery over lower abdomen area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Unit TENSAlso: PowerDotTENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Single unit TENS was administered via 2 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day. | Device | One Unit TENS |
| Two Unit TENSAlso: PowerDotTENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Double unit TENS was administered via 4 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day. | Device | Two Unit TENS |
Primary outcome
Analgesic effects of TENS on primary dysmenorrhea.
Time frame: 1 month
To determine whether TENS will reduce pain symptoms in those with primary dysmenorrhea. Subjective pain will be assessed using an 11 point visual analog scale (VAS). The scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
1 secondary outcome
Change in analgesic pill consumption during menstruation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 39066557McLagan B, Dexheimer J, Strock N, Goldstein S, Guzman S, Erceg D, Schroeder ET. The role of transcutaneous electrical nerve stimulation for menstrual pain relief: A randomized control trial. Womens Health (Lond). 2024 Jan-Dec;20:17455057241266455. doi: 10.1177/17455057241266455.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Schroeder, PhD principal investigator
Associated Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Unit TENS and Two Unit TENS in people with Primary Dysmenorrhea, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic effects of TENS on primary dysmenorrhea. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.